The Transitions Project: Supporting Adults During the Shift From Cancer Treatment to Surveillance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2023-11-01

Brief Summary

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This research study is designed to develop and test a new supportive care program to help individuals with lung cancer improve their quality of life after cancer treatment is over.

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Detailed Description

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The aims of this pilot study are to evaluate the feasibility and acceptability of a brief psychoeducational intervention for participants with cancer who are transitioning from active treatment to surveillance.

The research study procedures include screening for eligibility.

This study consists of 2 parts. It is expected that about 45 people will take part in this research study.

* In the first part of this study, about 5 participants will complete survey questions and receive a 5-session program.
* In the second part of this study, about 40 participants will complete 3 surveys, and then will be randomly assigned to receive the 5-session program or to receive one study session (control).
* These sessions will focus on providing targeted support related to life after cancer treatment. The sessions will focus on skills for coping with uncertainty, managing symptoms, improving social support, and other topics important to the individual.

Conditions

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Non Small Cell Lung Cancer Small-cell Lung Cancer Mesothelioma Cognitive Behavioral Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Run In

Participants will receive a 5-session psychoeducational intervention, focused on skills to enhance post-treatment quality of life with attention to (a) managing expectations, (b) coping with uncertainty, (c) self-managing residual symptoms and (d) strengthening social support.

Group Type EXPERIMENTAL

Run-In Sessions 1-5

Intervention Type BEHAVIORAL

Session 1 explores patient goals and wishes for life after cancer treatment with a study interventionist. Sessions 2-5 focuses on learning and practicing skills to enhance post-treatment quality of life.

Intervention

Participants will receive a 5-session psychoeducational intervention, focused on skills to enhance post-treatment quality of life with attention to (a) managing expectations, (b) coping with uncertainty, (c) self-managing residual symptoms and (d) strengthening social support.

Group Type EXPERIMENTAL

RCT Transitions Program Sessions 1-5

Intervention Type BEHAVIORAL

Sessions 1-5 focuses on learning and practicing skills to enhance post-treatment quality of life.

Control

Participants will receive a 1-session intervention, focused on reviewing goal progress for post-treatment quality of life, providing encouragement and support, identifying any current concerns, and providing tailored recommendations and resources.

Group Type ACTIVE_COMPARATOR

RCT Control Session

Intervention Type BEHAVIORAL

Participants will receive a 1-session intervention, focused on reviewing goal progress for post-treatment quality of life, providing encouragement and support, identifying any current concerns, and providing tailored recommendations and resources.

Interventions

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Run-In Sessions 1-5

Session 1 explores patient goals and wishes for life after cancer treatment with a study interventionist. Sessions 2-5 focuses on learning and practicing skills to enhance post-treatment quality of life.

Intervention Type BEHAVIORAL

RCT Transitions Program Sessions 1-5

Sessions 1-5 focuses on learning and practicing skills to enhance post-treatment quality of life.

Intervention Type BEHAVIORAL

RCT Control Session

Participants will receive a 1-session intervention, focused on reviewing goal progress for post-treatment quality of life, providing encouragement and support, identifying any current concerns, and providing tailored recommendations and resources.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age 21 or older
* Diagnosis of non-small cell (NSCLC) or small cell (SCLC) lung cancer or mesothelioma
* Documented treatment plan with curative intent
* Ability to read and respond in English
* Treatment completion eligibility:

Run-in: Has completed treatment including systemic treatments and radiation as determined within the past three weeks by the cancer care team at Massachusetts General Hospital.

RCT: Has completed treatment including systemic treatments +/- radiation and +/- surgery.

1. If final treatment is systemic therapy +/- radiation: within three weeks after cancer care team determination that treatment is complete.
2. If final treatment is surgery: within three weeks after hospital discharge following surgery.